NDC 70645-500 7t Gummy Es

Acetaminophen

NDC Product Code 70645-500

NDC Code: 70645-500

Proprietary Name: 7t Gummy Es What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331)
Shape: ROUND (C48348)
Size(s):
25 MM
Score: 1
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 70645 - 7t Pharma Llc

NDC 70645-500-88

Package Description: 8 TABLET, CHEWABLE in 1 CONTAINER

NDC Product Information

7t Gummy Es with NDC 70645-500 is a a human prescription drug product labeled by 7t Pharma Llc. The generic name of 7t Gummy Es is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: 7t Pharma Llc

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

7t Gummy Es Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • SUCROSE (UNII: C151H8M554)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • NEOTAME (UNII: VJ597D52EX)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • CORN SYRUP (UNII: 9G5L16BK6N)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: 7t Pharma Llc
Labeler Code: 70645
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

7t Gummy Es Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

7T Gummy ES is available as a chewable gel or gummy oral dosage form with improved organoleptic properties of taste, softness, chewiness, hardness, and translucency. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:In addition, each chewable gel contains the following inactive ingredients: hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

Clinical Pharmacology

Mechanism or ActionThe precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central nervous system actions.PharmacodynamicsTherapeutic doses of acetaminophen have negligible effects on the cardiovascular or respiratory systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing.PharmacokineticsAcetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. A small fraction (10 to 25%) of acetaminophen is bound to plasma proteins. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Acetaminophen is primarily metabolized in the liver by first-order kinetics and involves three principal separate pathways: conjugation with glucuronide; conjugation with sulfate; and oxidation via the cytochrome, P450-dependent, mixed-function oxidase enzyme pathway to form a reactive intermediate metabolite, which conjugates with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates. The principal cytochrome P450 isoenzyme involved appears to be CYP2E1, with CYP1A2 and CYP3A4 as additional pathways. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug.

Indications And Usage

7T Gummy ES is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

Warnings

  • Keep out of reach of children.Caution is advised for this formulation with extra strength dosing of acetaminophen due to the easily chewable gels and good taste. This is not a candy and the same caution with every medication should be applied to this product. Hepatotoxicity This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist. 3 or more alcoholic drinks every day while using this productAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products.The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals who ingest alcohol while taking acetaminophen.Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.Serious Skin ReactionsRarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.Acetaminophen may cause severe skin reactions. Symptoms may includeskin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away. Do not use if you are allergic to acetaminophen or any of the inactive ingredients in this product. Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Precautions

  • This formulation with extra strength acetaminophen should be taken under the supervision of a physician if: taking a blood thinning drug called warfarinyou or a family member have a history of high blood pressure or you are taking any antihypertensive medications due to the sodium content in each chewable gelyou or a family member have a history of diabetes or you are taking any diabetes medications due to the sugar content in each chewable gel

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.If pregnant or breast-feeding, consult a physician or health professional before use.

Overdosage

Following an acute overdosage, toxicity may result from acetaminophen. Clinical Presentation:Dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.Treatment of Overdose:Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage And Administration

  • Do not take more than directed (see overdose warning) Adults and children 12 years and over:take 2 chewable gels every 6 hours while symptoms last or as prescribed and directed by a physicianchew each chewable gel thoroughly before swallowingdo not take more than 6 chewable gels in 24 hours, unless directed by a physicianunder the supervision of a physician, daily doses up to 8 chewable gels may be useddo not take for more than 10 days unless prescribed and directed by a physician

Other Information

  • Each chewable gel contains: sodium 7.44 mg.each chewable gel contains: sugar 2g. store in a cool dry place between 20-25°C (68-77°F).Child Resistant Container; do not use if printed seal under cap is broken or missing.Inactive ingredients: hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

How Supplied

7T Gummy ES is supplied in the following dosage form:Eight (8) chewable gels per containerMade in USARx OnlyManufactured for: 7T Pharma, LLC220 Emerald Vista WayLas Vegas, NV 89144800.941.2848NDC: 70645-500-88 Size: 8 Chewable Gels

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